medical Class II Updated 2026-02-11

Changchun Wancheng Bio-Electron Co., Ltd. recalls Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration T

Recalled Product

Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test

Hazard / Issue

Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Name/Lot(Expiration): Vivoo Sodium Test/2024013123(01/30/2026); Vivoo Vitamin C Test/2024013124(01/30/2026); Vivoo Hydration Test/2024013119(01/30/2026), 2025051519(05/14/2027)
View official government recall

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